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European court upholds restriction on sale of food supplements

BMJ 2005; 331 doi: (Published 21 July 2005) Cite this as: BMJ 2005;331:180
  1. Rory Watson
  1. Brussels

    The European Union's highest court has upheld proposed restrictions on the sale of food supplements—a setback to critics of the legislation, who claim that it would ban hundreds of popular vitamin pills.

    The legislation, which was approved three years ago, establishes a list of vitamins and minerals that may be used in food supplements and lays down criteria on labelling to ensure that consumers are better informed about their contents.

    The measures are designed to maintain a high level of protection of public health and to enable approved supplements to be sold throughout the EU. Previously, different national regulations meant that many products could be sold in some countries but not others.

    Under the new rules, which will come into force on 1 August, only dietary supplements on the approved list may go on sale. However, any products that were already on the market before July 2002 will be given a four year extension, provided that the manufacturer had made an application to go on the approved list by 12 July, and the EU's food safety agency does not reject them during this period. UK based manufacturers have made more use of this than many others, having submitted some 500 applications.

    Led by the Alliance for Natural Health and the National Association of Health Stores, opponents challenged the legislation in the High Court in England, which referred the case to the European Court of Justice, which is based in Luxembourg.

    The campaigners received a boost in April, when the advocate general, the senior lawyer who advises the judges at the European court, maintained that the rules were disproportionate and violated some basic legal principles.

    However, the full court decided otherwise, ruling that the legislation was “appropriate for securing the free movement of food supplements and ensuring the protection of human health.”

    How the ruling will effect the number of supplements that may be sold is unclear. Critics maintain that the new regulation will outlaw up to 300 commonly used vitamins and minerals and lead to the removal of more than 5000 products now on sale in Europe.

    However, the Bureau Européen des Unions de Consommateurs, Europe's main umbrella group for consumer organisations, has welcomed the court's ruling. Its director, Jim Murray, said: “We are pleased that the court rejected the misguided and unfounded attack by vested interests on the validity of the directive.”

    The European Commission has also denied that many items will now have to be removed. “It is not our aim to take products off the shelves. It is our aim to make sure these products are safe,” a spokesman said.

    He pointed out that the British Food Standards Agency had already accepted 500 applications from British companies for their products to be placed on the list of allowable vitamins and minerals.

    The court's ruling also insisted that procedures for rejecting a product from the approved list had to be “consistent with the principles of sound administration and legal certainty.” It emphasised that a product could be refused only “on the basis of a full risk assessment, established on the basis of the most reliable scientific data.”

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